Nicotinamide for skin cancer prevention
Oral nicotinamide 500 mg twice daily vs. Placebo · for Nonmelanoma skin cancer (high-risk patients) · real-time analysis of 1 studies · updated 2026-05-29
In patients with a history of nonmelanoma skin cancer, oral nicotinamide (vitamin B3) for 12 months reduced new nonmelanoma skin cancers by about 23%, with similar reductions in basal- and squamous-cell carcinomas and in actinic keratoses. It is inexpensive, over-the-counter, and well tolerated, but the benefit fades once it is stopped.
Efficacy (RCT): Efficacy evidence on clinical outcomes. Effects are risk ratios with number-needed-to-treat where a baseline risk is available. Glossary →
Outcomes are lesion rate ratios, so NNTs are per skin cancer prevented over 12 months—strikingly low here because high-risk patients get many lesions, and not transferable to average-risk people. The benefit disappears within months of stopping. Evidence is a single phase 3 trial; the basal-cell result was not significant and squamous-cell was borderline.
Forest plot—New nonmelanoma skin cancers
Study results—New nonmelanoma skin cancers
| Study | Design | Dose / regimen | Treatment | Control | RR [95% CI] | Improvement | NNT | Weight |
|---|---|---|---|---|---|---|---|---|
| ONTRAC (Chen) 2015 note | DB-RCT | Nicotinamide 500 mg twice daily | — | — | 0.77 [0.62–0.96] | 23% | 2 | 100% |
RR < 1 favors treatment for outcomes where lower is better. Rows in gray have a confidence interval crossing 1 (individually inconclusive). “~” marks effects reported as OR/HR and treated as RR-approximations. “excl” = excluded from pooling (e.g. reviews).
Notes & interpretation
- ONTRAC (Chen) 2015—New nonmelanoma skin cancers (primary). Rate ratio from 23% lower (95% CI 4-38), P=0.02. Control rate 2.4 lesions/person/12 mo; NNT is per cancer prevented over 12 months.
Forest plot—Basal-cell carcinoma
Study results—Basal-cell carcinoma
| Study | Design | Dose / regimen | Treatment | Control | RR [95% CI] | Improvement | NNT | Weight |
|---|---|---|---|---|---|---|---|---|
| ONTRAC (Chen) 2015 note | DB-RCT | Nicotinamide 500 mg twice daily | — | — | 0.80 [0.61–1.06] | 20% | 3 | 100% |
RR < 1 favors treatment for outcomes where lower is better. Rows in gray have a confidence interval crossing 1 (individually inconclusive). “~” marks effects reported as OR/HR and treated as RR-approximations. “excl” = excluded from pooling (e.g. reviews).
Notes & interpretation
- ONTRAC (Chen) 2015—Basal-cell carcinoma. Rate ratio from 20% lower (95% CI -6 to 39), P=0.12 (not significant). Reduction was mainly in superficial BCCs.
Forest plot—Squamous-cell carcinoma
Study results—Squamous-cell carcinoma
| Study | Design | Dose / regimen | Treatment | Control | RR [95% CI] | Improvement | NNT | Weight |
|---|---|---|---|---|---|---|---|---|
| ONTRAC (Chen) 2015 note | DB-RCT | Nicotinamide 500 mg twice daily | — | — | 0.70 [0.49–1.00] | 30% | 5 | 100% |
RR < 1 favors treatment for outcomes where lower is better. Rows in gray have a confidence interval crossing 1 (individually inconclusive). “~” marks effects reported as OR/HR and treated as RR-approximations. “excl” = excluded from pooling (e.g. reviews).
Notes & interpretation
- ONTRAC (Chen) 2015—Squamous-cell carcinoma. Rate ratio from 30% lower (95% CI 0 to 51), P=0.05 (borderline).
Background
Nicotinamide (vitamin B3) aids DNA repair and reduces UV immunosuppression. The phase 3 ONTRAC trial randomized 386 high-risk patients (≥2 prior nonmelanoma skin cancers) to nicotinamide 500 mg twice daily or placebo for 12 months. The effect was not maintained after stopping and is not established in average-risk people.
Topic methodology & caveats
Studies
- 2015 · DB-RCT Chen AC, Martin AJ, Choy B, et al. A Phase 3 Randomized Trial of Nicotinamide for Skin-Cancer Chemoprevention (ONTRAC). N Engl J Med. 2015;373(17):1618-1626.
- 2015 · DB-RCT Chen AC, Martin AJ, Choy B, et al. A Phase 3 Randomized Trial of Nicotinamide for Skin-Cancer Chemoprevention (ONTRAC). N Engl J Med. 2015;373(17):1618-1626.
- 2015 · DB-RCT Chen AC, Martin AJ, Choy B, et al. A Phase 3 Randomized Trial of Nicotinamide for Skin-Cancer Chemoprevention (ONTRAC). N Engl J Med. 2015;373(17):1618-1626.